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Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
hENT1
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Adjuvant chemotherapy, hENT1, Gemcitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with curatively resected pancreatic cancer
  • Age between 18 and 75
  • Eastern Cooperative Oncology Group performance score 0 or 1
  • Patients with compliance
  • Patients with informed consent

Exclusion Criteria:

  • Patients refuse to enroll this study
  • Patients with concomitant chemoradiation therapy
  • Previous chemotherapy
  • Pregnant or preparing a pregnancy
  • Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months
  • Enrolled another clinical trial within 30 days
  • Patients will be expected to be risk because of enrollment
  • Patients without informed consent

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5-FU group

Gemcitabine group

Arm Description

Grades of hENT1 immunostaining are 0 or 1.

Grade of hENT1 immunostaining is 2.

Outcomes

Primary Outcome Measures

Recurrence free survival

Secondary Outcome Measures

Overall survival
Toxicity
Hematologic and hepatic toxicity according to blood test results & non-hematologic toxicity (fatigue, vomiting, diarrhea, sensory neuropathy) according to CTCAE 4.0 scale

Full Information

First Posted
June 23, 2015
Last Updated
September 21, 2017
Sponsor
Seoul National University Hospital
Collaborators
IlDong Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02486497
Brief Title
Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining
Official Title
Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
IlDong Pharmaceutical Co Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-FU).
Detailed Description
After surgical resection of pancreatic cancer, the tissue is immunostained by hENT1 antibody. The grades of immunostaining are categorized as 0 (0%), 1 (<50%), and 2 (>=50%). According to the grade, patients with grade 0 or 1 will be treated with 5-FU and those with grade 2 will be treated with gemcitabine. After the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hENT1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Adjuvant chemotherapy, hENT1, Gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-FU group
Arm Type
Active Comparator
Arm Description
Grades of hENT1 immunostaining are 0 or 1.
Arm Title
Gemcitabine group
Arm Type
Active Comparator
Arm Description
Grade of hENT1 immunostaining is 2.
Intervention Type
Biological
Intervention Name(s)
hENT1
Intervention Description
hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.
Primary Outcome Measure Information:
Title
Recurrence free survival
Time Frame
Upto 24 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Upto 24 weeks
Title
Toxicity
Description
Hematologic and hepatic toxicity according to blood test results & non-hematologic toxicity (fatigue, vomiting, diarrhea, sensory neuropathy) according to CTCAE 4.0 scale
Time Frame
Upto 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with curatively resected pancreatic cancer Age between 18 and 75 Eastern Cooperative Oncology Group performance score 0 or 1 Patients with compliance Patients with informed consent Exclusion Criteria: Patients refuse to enroll this study Patients with concomitant chemoradiation therapy Previous chemotherapy Pregnant or preparing a pregnancy Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months Enrolled another clinical trial within 30 days Patients will be expected to be risk because of enrollment Patients without informed consent
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33795193
Citation
Shin DW, Lee JC, Kim J, Yoon YS, Han HS, Kim H, Hwang JH. Tailored adjuvant gemcitabine versus 5-fluorouracil/folinic acid based on hENT1 immunohistochemical staining in resected pancreatic ductal adenocarcinoma: A biomarker stratified prospective trial. Pancreatology. 2021 Jun;21(4):796-804. doi: 10.1016/j.pan.2021.02.022. Epub 2021 Mar 4.
Results Reference
derived

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Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining

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